Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma Symptoms
- Conditions
- Bronchial Asthma
- Interventions
- Drug: Beclomethasone dipropionate/Salbutamol combination
- Registration Number
- NCT00497523
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
To demonstrate a superior efficacy of BDP plus rescue salbutamol suspension for nebulisation, compared to placebo plus rescue salbutamol, in the relief of symptoms of asthma in young children with persistent symptoms of asthma.
- Detailed Description
Asthma is a chronic disease which is estimated to affect over 25 million people both in the US and Europe(i.e. approximately 10% of the total population).There is evidence that over the last 20 years prevalence has considerably increased, especially among children. The diagnosis of asthma in children may be difficult, largely because episodic wheezing and cough are among the common symptoms encountered in childhood illnesses, particularly in children under 3 years old.Although in these young children there is the possibility of over treatment, the episodes of wheezing may be reduced in intensity by the effective use of anti-inflammatory medications and bronchodilators rather than antibiotics. At present, pharmacological therapy is used to treat reversible airway obstruction, inflammation and hyperreactivity in both children and adults. Medications include preventive treatments in forms of antinflammatory/antiallergic agents (e.g. glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever treatments, in form of bronchodilators (e.g. β-adrenergic agonists, anticholinergics). Comparisons: Beclomethasone suspension for nebulisation (400 mcg U.D.V.) plus as needed salbutamol compared to placebo plus as needed salbutamol and to as needed salbutamol/beclomethasone fixed combination.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 283
Patients will be enrolled into the 2-week placebo run-in period if they meet all the following criteria:
- Age ≥ 1 year and ≤ 4 years.
- At least 3 episodes of wheeze or asthma-like symptoms in the 6 months preceding the study entry.
- A cooperative attitude and ability to be trained to inhale correctly from the device and to complete the diary cards.
- Written parental/guardian informed consent obtained.
Patients will be then randomised to the treatment period if they meet all the previous criteria plus:
- Presence in at least 7 days out of the 14 days of the run-in period of at least one of the following symptoms: wheeze, cough or shortness of breath; or had required at least one dose of relief salbutamol.
- History of severe asthma exacerbation or exacerbations requiring hospitalisation in the previous 4 weeks.
- Symptomatic infection of the airways requiring treatment with antibiotics or antimycotics in the previous 4 weeks.
- Treatment with inhaled steroids in the previous 4 weeks or oral steroids in the previous 8 weeks.
- Treatment with methyl-xantine derivatives in the previous 4 weeks.
- Treatment with long-acting β2-agonists in the previous 2 weeks.
- Changes in asthma medications taken on regular basis in the previous 4 weeks.
- Symptoms of asthma limited to seasonal allergen exposure.
- History of clinically significant cardiac, renal, neurologic, hepatic, endocrine or pulmonary disease (except asthma), or laboratory testing abnormalities, whose sequelae and/or treatments can interfere with the results of the present study.
- Evidence of pulmonary malformations.
- Evidence of immunological deficiency (patients to be withdrawn if diagnosed during the study).
- Cancer or any other chronic disease with prognosis < 2 years.
- Hypersensitivity to inhaled corticosteroids.
- Participation in another trial in the last 4 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Beclomethasone dipropionate/Salbutamol combination Beclomethasone dipropionate/Salbutamol combination - Salbutamol Salbutamol - Beclomethasone dipropionate Beclomethasone dipropionate -
- Primary Outcome Measures
Name Time Method Percentage of global (weeks 1-12) symptom-free days. weeks 1-12
- Secondary Outcome Measures
Name Time Method time to first exacerbation weeks 1-12 Single clinical symptoms weeks 1-12 and every 2-week period Nocturnal awakening due to symptoms of asthma weeks 1-12 and every 2-week period Frequency and number of exacerbations (defined as a worsening of symptoms of asthma requiring extra oral or inhaled corticosteroids) weeks 1-12 Use of rescue nebulised therapy weeks 1-12 and every 2-week period
Trial Locations
- Locations (19)
Zaklad Alergologii Dzieciecej
🇵🇱Bialystok, Poland
Wojskovy Szpital Klinikzny
🇵🇱Krakow, Poland
Priwtny Gabinet Pediatriczno - Alergologiczny
🇵🇱Rabka Zdroj, Poland
City Children's Clinical Hospital n. 2, Dniepropetrovs'k State Medical Academy, Department of preliminary study of childhood disesas
🇺🇦Dniepropetrovsk, Ukraine
Institute of Pediatrics, Obstetrics and Gynecology. Department of Children's Pulmonology Diseases and Ecological Problems of Health
🇺🇦Kyiv, Ukraine
Poltava regional children's clinical hospital, Ukranian stomatological academy, department of pediatrics
🇺🇦Poltava, Ukraine
Children's clinical hospital N.1, Zaporizzhya Medical Academy of post graduate education, department of pediatrics
🇺🇦Zaporizhya, Ukraine
City Clinical Hospital N. 1 , Zaporizzhya Medical Academy of post graduate education, department of paediatrics
🇺🇦Zaporizhya, Ukraine
Alergovita, alergologia Dziecieca
🇵🇱Lublin, Poland
Priwatna Pomoc Lekarska
🇵🇱Lodz, Poland
Department of Hospital Pediatrics, Kharkiv State Medical University Region Clinical Children's Hospital n. 2
🇺🇦Kharkiv, Ukraine
Department of Clinical rehabilitation of children with bodily diseasesof Institute of Pediatrics, Obstetrics and Gynecology
🇺🇦Kyiv, Ukraine
Respiratory Diseases Children's Clinic, Institute of Phthisiology and Pulmonology,Academy of Medical Science of the Ukraine, Pulmonology
🇺🇦Kiev, Ukraine
Department of Paediatric and Neonatology, Odessa State Medical University, Odessa Region Clinical Children's Hospital
🇺🇦Odessa, Ukraine
Dniepropetrovsk Regional Children's Clinical Hospital, State Medical Academy, Hospital Paediatric Department N.1
🇺🇦Dniepropetrovsk, Ukraine
Regional Children Clinical Hospital. Department of Pulmonology.
🇺🇦Zaporizhya, Ukraine
Specjalistyczne Centrum Leczenia Dzieci i Mlodziezy
🇵🇱Krakow, Poland
Pediatrics Crimean State Medical University Pulmonology, Department of Republican Clinical Children's Hospital
🇺🇦Simferopol, Ukraine
Children's Hospital "OHMATDYT" Department of Pediatrics N. 1 of Kyiv Medical Academy of Postgraduate Education
🇺🇦Kyiv, Ukraine